盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973792173794313795953791133797013794110.07
211.993795303791323793310.08
单位质量响应值RSD%判断
31696.8331637.280.14数据可信
供试品溶液-2024072521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195870-9587045.89445.3418.3445.8945.3418.34
2121520-12152058.17358.17
373820-7382035.33935.34
499853-9985347.80147.80
599776-9977647.76447.76
677394-7739437.05037.05
10min1129996-12999662.23160.1211.7762.3160.2011.77
2142503-14250368.21868.32
3107182-10718251.31051.37
4133658-13365863.98464.06
5132803-13280363.57563.65
6107424-10742451.42551.49
15min1144773-14477369.30566.3710.5769.4966.5510.58
2155284-15528474.33774.55
3120052-12005257.47157.62
4146375-14637570.07270.26
5144544-14454469.19569.38
6120820-12082057.83857.99
20min1157195-15719575.25270.759.4375.5571.039.44
2161564-16156477.34377.68
3130148-13014862.30462.54
4155419-15541974.40174.70
5152025-15202572.77773.08
6130353-13035362.40262.65
30min1172780-17278082.71277.587.5383.1377.987.54
2175242-17524283.89184.35
3149256-14925671.45171.80
4166161-16616179.54479.97
5163297-16329778.17378.59
6145562-14556269.68370.03
45min1187158-18715889.59584.265.3890.1584.805.40
2184438-18443888.29388.90
3168676-16867680.74881.21
4175764-17576484.14184.70
5178015-17801585.21885.77
6162066-16206677.58378.05
60min1192658-19265892.22888.393.3092.9489.063.33
2190721-19072191.30192.05
3180302-18030286.31386.91
4180487-18048786.40287.10
5185844-18584488.96689.66
6177852-17785285.14085.73
90min1202112-20211296.75491.934.2297.6292.754.23
2197658-19765894.62295.52
3193571-19357192.66593.41
4187200-18720089.61590.46
5192570-19257092.18693.03
6179068-17906885.72386.46
120min1204822-20482298.05193.324.4599.0794.294.45
2199270-19927095.39496.45
3197182-19718294.39495.29
4189634-18963490.78191.77
5198391-19839194.97395.97
6180337-18033786.33087.21
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1205580-20558098.41495.312.9699.6096.442.97
2200505-20050595.98597.20
3200745-20074596.10097.15
4192567-19256792.18593.33
5203888-20388897.60498.76
6191294-19129491.57592.60
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973816513815583818203813843809423814710.09
211.993813453816503814980.06
单位质量响应值RSD%判断
31868.9231818.020.12数据可信
供试品溶液-2024072521批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106789-10678950.83850.094.5650.8450.094.56
2107661-10766151.25351.25
3105611-10561150.27750.28
496360-9636045.87345.87
5110426-11042652.57052.57
6104443-10444349.72149.72
10min1141173-14117367.20768.393.5567.2968.483.55
2148204-14820470.55470.64
3148120-14812070.51470.60
4135065-13506564.29964.38
5146547-14654769.76669.85
6142860-14286068.01068.09
15min1153051-15305172.86274.143.3973.0674.333.39
2159431-15943175.89976.10
3162062-16206277.15277.35
4147014-14701469.98870.17
5157029-15702974.75674.96
6155766-15576674.15474.35
20min1166257-16625779.14978.633.3479.4778.953.34
2167918-16791879.93980.27
3172893-17289382.30882.64
4156300-15630074.40974.71
5164465-16446578.29678.62
6163109-16310977.65077.97
30min1172090-17209081.92684.224.2982.3884.674.28
2180411-18041185.88786.35
3189874-18987490.39290.86
4167989-16798979.97380.40
5176126-17612683.84784.31
6174936-17493683.28083.73
45min1181753-18175386.52691.229.1587.1191.819.10
2190536-19053690.70791.31
3226594-226594107.873108.49
4180143-18014385.75986.32
5186185-18618588.63689.23
6184485-18448587.82688.41
60min1187183-18718389.11191.443.4389.8492.183.44
2196767-19676793.67394.43
3203037-20303796.65897.46
4186156-18615688.62289.32
5190989-19098990.92391.67
6188297-18829789.64190.38
90min1191812-19181291.31594.123.0092.1995.023.01
2202785-20278596.53897.45
3206633-20663398.37099.33
4192345-19234591.56892.42
5197524-19752494.03494.93
6195182-19518292.91993.80
120min1201564-20156495.95795.422.6896.9996.472.69
2203996-20399697.11598.19
3208065-20806599.052100.17
4192780-19278091.77592.78
5199238-19923894.85095.90
6196973-19697393.77194.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1193699-19369992.21395.252.8693.4096.462.87
2203693-20369396.97198.21
3209497-20949799.734101.02
4196296-19629693.44994.60
5199751-19975195.09496.31
6197502-19750294.02395.22
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973821903818013815273819753816313818250.07
211.993820123825273822700.10
单位质量响应值RSD%判断
31898.5031882.400.04数据可信
供试品溶液-2024072522批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125951-12595159.87255.7810.2159.8755.7810.20
2103549-10354949.22349.22
3114543-11454354.44954.45
4113921-11392154.15454.15
5109528-10952852.06552.07
6136617-13661764.94264.94
10min1146025-14602569.41564.944.4569.5165.044.45
2127833-12783360.76760.85
3134533-13453363.95264.04
4135677-13567764.49664.59
5135548-13554864.43464.52
6140079-14007966.58866.70
15min1159156-15915675.65771.744.3875.8771.944.38
2144151-14415168.52468.71
3149208-14920870.92871.12
4157684-15768474.95775.15
5143490-14349068.21068.40
6151802-15180272.16172.38
20min1167157-16715779.46075.763.0779.8076.083.07
2155475-15547573.90774.20
3158964-15896475.56575.88
4160418-16041876.25676.58
5153146-15314672.80073.11
6161145-16114576.60276.94
30min1179029-17902985.10382.391.9585.5882.841.97
2171720-17172081.62982.05
3172321-17232181.91582.36
4174418-17441882.91283.36
5168894-16889480.28680.71
6173561-17356182.50482.97
45min1190042-19004290.33988.111.3190.9588.701.31
2184792-18479287.84388.40
3183570-18357087.26287.84
4185717-18571788.28388.87
5184085-18408587.50788.07
6183973-18397387.45488.06
60min1209924-20992499.79092.463.96100.5693.193.95
2193134-19313491.80892.51
3188891-18889189.79190.51
4191508-19150891.03591.77
5191049-19104990.81791.53
6192505-19250591.50992.26
90min1197878-19787894.06393.341.0795.0094.221.06
2198743-19874394.47595.33
3194358-19435892.39093.26
4196958-19695893.62694.51
5196875-19687593.58794.45
6193327-19332791.90092.80
120min1198104-19810494.17194.201.0395.2695.241.02
2201057-20105795.57596.59
3194961-19496192.67793.70
4197131-19713193.70894.75
5198705-19870594.45795.47
6199016-19901694.60495.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1198759-19875994.48293.991.4795.7395.181.45
2200819-20081995.46296.63
3193833-19383392.14193.32
4198070-19807094.15595.35
5200228-20022895.18196.35
6194605-19460592.50893.72
盐酸伐地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.973817333817883814053813063806263813720.13
211.993817813818433818120.02
单位质量响应值RSD%判断
31860.6531844.200.04数据可信
供试品溶液-2024072522批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197524-9752446.41455.109.3246.4155.109.33
2124580-12458059.29159.29
3115877-11587755.14955.15
4110866-11086652.76452.76
5118069-11806956.19256.19
6127692-12769260.77260.77
10min1119978-11997857.10166.198.1057.1866.288.10
2146931-14693169.92970.03
3140947-14094767.08167.17
4133942-13394263.74763.83
5140233-14023366.74166.83
6152360-15236072.51272.61
15min1138225-13822565.78573.326.2265.9673.536.22
2159416-15941675.87176.09
3156661-15666174.55974.76
4147671-14767170.28170.48
5157402-15740274.91275.12
6164996-16499678.52678.75
20min1149631-14963171.21479.027.0671.5079.357.05
2166412-16641279.20079.54
3183499-18349987.33287.66
4159116-15911675.72876.04
5163869-16386977.99078.32
6173730-17373082.68383.04
30min1168997-16899780.43084.743.4680.8385.203.48
2177378-17737884.41984.89
3183292-18329287.23487.71
4175443-17544383.49883.94
5176757-17675784.12484.58
6186489-18648988.75589.25
45min1178840-17884085.11590.043.5285.6590.643.54
2187225-18722589.10689.72
3196418-19641893.48194.10
4188323-18832389.62890.20
5187705-18770589.33489.93
6196637-19663793.58594.22
60min1186849-18684988.92793.103.1089.6093.843.11
2191949-19194991.35492.12
3203129-20312996.67597.45
4194423-19442392.53193.26
5195813-19581393.19393.94
6201499-20149995.89996.69
90min1193189-19318991.94495.093.1592.7795.993.16
2195229-19522992.91593.83
3208209-20820999.093100.03
4199348-19934894.87595.76
5196074-19607493.31794.22
6206727-20672798.38799.34
120min1196422-19642293.48396.002.9494.4697.062.95
2196309-19630993.42994.50
3209962-20996299.927101.03
4201078-20107895.69996.74
5198504-19850494.47495.53
6208018-20801899.002100.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1197239-19723993.87295.842.8795.0197.062.87
2194962-19496292.78894.01
3209134-20913499.533100.80
4201681-20168195.98697.18
5197869-19786994.17195.39
6207309-20730998.66499.95
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